Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab

McNeil AB84 enrolled

Overview

The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.

The trial has a single-dose, randomized, crossover design and includes 84 subjects. The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Tobacco Dependence

Interventions

Code STDDRUG

2 mg Single-dose of experimental nicotine product coded "STD"

Code STEDRUG

2 mg Single-dose of experimental nicotine product coded "STE"

Nicorette MicrotabDRUG

A comparative 2 mg Single-dose of marketed tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2. * Female participants of child-bearing potential are required to use a medically acceptable means of birth control. * A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. Exclusion Criteria: * Pregnancy, lactation or intended pregnancy. * Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Locations (1)

McNeil AB Clinical Pharmacology R&D

Lund, Sweden

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax)

Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)

Time frame: During 10 hours post-dose

Area Under the Curve [AUC(0-t)]

Bioavailability within the Set Period \[AUC(0-t)\] is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour \* nanograms (ng) per milliliter (mL).

Time frame: During 10 hours post-dose

AUC(0-∞)

AUC (0-∞) is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. It is obtained from calculating AUC (0-t) plus AUC (t-∞).

Time frame: 10 hours post-dose

Secondary Outcomes

Product Dissolution Time

Product Dissolution Time is the time from administration until the investigational products were completely dissolved.

Time frame: During 10 hours post-dose

Data from ClinicalTrials.gov

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